ClinicalTrials.gg
RecruitingNCT07832045EASE-MBOUpdated Sep 21, 2026

Endoscopic Ultrasound Guided Hepaticogastrostomy With or Without Antegrade Stenting for Palliation of Malignant Distal Biliary Obstruction: Randomized Controlled Trial

An interventional study of HGAS and HGS in Malignant Biliary Obstruction and Malignant Biliary Stricture, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2026, registered Sep 2026).
  • Started Apr 2026; still recruiting 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy and safety between EUS-HGAS and EUS-HGS. We hypothesized that EUS-HGAS provides lower recurrent biliary obstruction (RBO) rate but with a comparable safety profile to EUS-HGS.

02

Conditions studied

  • Malignant Biliary Obstruction
  • Malignant Biliary Stricture

Keywords

  • malignant biliary obstruction
  • EUS-guided hepaticogastrostomy
  • EUS-guided antegrade stenting
  • Biliary obstruction
03

In context

Constriction, Pathologic

456 studies on the registry are indexed under Constriction, Pathologic; 109 are open to participants now.

This study's planned enrollment of 88 is above the median of 72 across 295 interventional studies indexed under Constriction, Pathologic.

Browse Constriction, Pathologic studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 years or older with malignant distal biliary obstruction
  • Failed ERCP
  • The papilla is inaccessible owing to a surgically altered anatomy or gastric outlet obstruction

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 18 years old
  • Cancer infiltration of the gastric/duodenal wall within the planned puncture route
  • Patients with uncorrectable coagulopathy
  • Patients with unmanageable ascites
  • Patients with serious comorbidities that prohibited endoscopic management
  • Patients with pregnancy
  • Patients who cannot or refuse to provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (estimated)

Study arms

  • Active comparator
    HGS

    Endoscopic ultrasound guided hepaticogastrostomy

    Device: HGS

  • Experimental
    HGAS

    Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting through the major papilla

    Device: HGAS

Interventions

  • DeviceHGAS

    Endoscopic ultrasound guided hepaticogastrostomy with antegrade stenting

  • DeviceHGS

    Endoscopic ultrasound guided hepaticogastromy

06

What researchers measure

Primary outcomes

  1. Recurrent biliary obstruction (RBO) rate

    the proportion of participants experiencing RBO, defined by cholangitis, jaundice or findings of images, from index day of EUS-BD to the date of last follow-up

    Time frame: From enrollment to the end of follow-up up to 12 months

Secondary outcomes

  1. Time to Recurrent Biliary Obstruction

    Time frame: From date of enrollment until the date of first documented recurrent biliary obstruction, date of death from any cause or date of last follow-up, whichever came first, assessed up to 12 months

  2. Tract dilation success

    tract dilation was regarded as successful when the maximum diameter portion of the first dilator into the bile duct

    Time frame: From the start of the EUS-BD to completion or failure of dilation, assessed on the day of the drainage procedure

  3. Final procedure success

    a successful deployment of a stent in the intended location

    Time frame: From the start of the EUS-BD to completion or failure of stent deployment, assessed on the day of the drainage procedure

  4. Procedural duration

    Time frame: The time elapsed between puncture of the intrahepatic duct and completion of deployment of stent, assessed on the day of the drainage procedure.

  5. Clinical success

    Time frame: a decrease in bilirubin within 14 days to < 50 % of levels before EUS-BD

  6. Adverse events

    bleeding (hematemesis and/or melena or hemoglobin drop over 2g/dL, needed blood transfusion, endoscopic hemostasis, radiological intervention or surgery), pancreatitis, cholangitis, peritonitis, and perforation, in accordance with the American Society for GI Endoscopy lexicon

    Time frame: From the day of procedure to the completion of follow-up up to 12 months

  7. Length of hospital stay after procedure

    Time frame: From the day of procedure to discharge, assessed up to 12 months

  8. Overall survival

    Time frame: Survival rate at the end of the follow-up period, assessed up to 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Ishiwatari H, Ogura T, Hijioka S, Iwashita T, Matsubara S, Ishikawa K, Niiya F, Sato J, Okuda A, Ueno S, Nagashio Y, Maruki Y, Uemura S, Notsu A. EUS-guided hepaticogastrostomy versus EUS-guided hepaticogastrostomy with antegrade stent placement in patients with unresectable malignant distal biliary obstruction: a propensity score-matched case-control study. Gastrointest Endosc. 2024 Jul;100(1):66-75. doi: 10.1016/j.gie.2024.02.012. Epub 2024 Feb 19. PubMed 38382887 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07832045
Collaborators
National Taiwan University Hospital Hsin-Chu Branch, Chang Gung Memorial Hospital, Taichung Veterans General Hospital, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Shin Kong Wu Ho-Su Memorial Hospital, Far Eastern Memorial Hospital, China Medical University Hospital, Chung Shan Medical University, Taitung Mackay Memorial Hospital, National Cheng-Kung University Hospital
Responsible party
Sponsor
First posted
Sep 21, 2026
Start date
Apr 1, 2026
Primary completion
Jul 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Sep 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion